Home GUDID E314SURGICASEKNEEPLAN0 SurgiCase Planner
Primary DI E314SURGICASEKNEEPLAN0
Brand SurgiCase Planner
Company Materialise NV
Model SurgiCase Knee Planner
Catalog number SurgiCase Knee Planner
Device description SurgiCase Knee Planner
Published 2018-10-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic 2 JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2 OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E314SURGICASEKNEEPLAN0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition CAD/CAM software A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing). It may include functionality to upload patient-specific images and to facilitate communication between healthcare professionals.
Regulatory Flags# DUNS number 373139427 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097536705 Identity CR KA Restor3d, Inc. OIY 2026-09-25 00840097536705 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536705 Identity CR KA Restor3d, Inc. OOG 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. OOG 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. OIY 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25